Datar Cancer Genetics announced FDA clearance for its CellDx-Tissue comprehensive genomic profiling assay to profile DNA and RNA from solid tumors. The dual-analyte targeted next-generation sequencing test assesses single nucleotide variants, small insertions/deletions, and ERBB2 gene amplification across 517 cancer-associated genes, with RNA-based calls for ALK, RET, and ROS1 fusions. The company said the test can be run on formalin-fixed, paraffin-embedded samples and is performed globally in CAP- and CLIA-accredited laboratories. Datar positioned the clearance as a bridge between genomic complexity and clinical decision-making as targeted therapies expand.